CUBRETE ANTISEPTIC HAND SANITIZER- ethyl alcohol gel 
Frozen Wheels, Llc

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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CUBRE T® HAND SANITIZER GEL

Drug Facts

Active ingredient

Ethyl alcohol 70%v/v

Purpose

Antimicrobial

Uses

Warnings

Flammable

• Keep away from fire or flame. • For external use only.

When using this product

• Do not use it in or near the eyes. • In case of contact, rinse eyes thoroughly with water.

Stop use and ask a doctor if skin irritation occurs.

Keep out of reach of children. If swallowed, get medical help in a Poison Control Center immediately.

Directions

Other information

• Store below 110°F (43°C) • May discolor certain fabrics

Inactive Ingredients Triethanolamine, Carbomer, Polysorbate, Water, Glycerin.

Questions?

+52 1 56 1876 7678    info@cubret.mx

Alcohol Based

Manufactured by: Corporativo Cubrete, S.A. de C.V. Calzada las Aguilas 1709, Interior B, Lomas de Guadalupe, Alvaro Obregon, C.P.01720 Made in Mexio

Imported by: Frozen Wheels, LLC 16565 NW 15th Ave. Miami, FL 33169

HECHO EN

MEXICO

Packaging

untitled

Packaging

untitled

CUBRETE ANTISEPTIC HAND SANITIZER 
ethyl alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77031-105
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
TROLAMINE (UNII: 9O3K93S3TK)  
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:77031-105-0250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/08/2020
2NDC:77031-105-04125 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/08/2020
3NDC:77031-105-08250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/08/2020
4NDC:77031-105-16500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/08/2020
5NDC:77031-105-331000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/08/2020
6NDC:77031-105-014000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/08/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A07/08/2020
Labeler - Frozen Wheels, Llc (069055731)

Revised: 7/2020
Document Id: 22dc820f-494c-4ec7-9148-5a80b01130ce
Set id: 0e63e35a-a21a-4939-abbd-7d88fc877ef9
Version: 1
Effective Time: 20200708
 
Frozen Wheels, Llc